10
Participants
Start Date
June 18, 2018
Primary Completion Date
October 13, 2019
Study Completion Date
October 13, 2019
"Conditioning treatment Thiotepa-Treosulfan-Fludarabine"
Thiotepa iv 5 mg/kg/bid (total dose TD 10 mg/kg) day -3,-2; Treosulfan iv 14g/mq/day (TD 42 g/mq) as a single daily dose day -6, -5, -4; Fludarabine iv 30 mg/m2 (TD 150 mg/m2) day -6, -5, -4, -3, -2. Thiotepa TD 5 mg/kg and treosulfan TD 36 g/mq dose reduction according to age \> 65 years.
PBSC graft
(target 4-8 × 106 CD34+ cells/kg patient body weight)
GvHD prophylaxis
"Sirolimus orally, monitored two times a week to maintain a target therapeutic plasma level of 8-15 ng/ml from day +5.~Mycophenolate 15 mg/kg bid i.v. or per os day +5 through +28. Cyclophosphamide 50 mg/kg i.v. day +3+4. Mesna: \>80% of the cyclophosphamide dose in 3 divided doses from day +3 daily through day +5."
Primary antifungal prophylaxis
Posaconazole delayed-release tablet \[available in 100 mg tablets\]: 300 mg twice daily on the first day followed by a maintenance dose of 300 mg once a day, starting on the day 0 to day 85.
Ospedale San Raffaele, Milan
Ciceri Fabio
OTHER